Koronis Pharmaceuticals` Scientific Advisory Board Confirms KP-1461 Clinical Drug Activity, HIV Ablation

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Tue May 19, 2009 8:07am EDT

SEATTLE--(Business Wire)--
Koronis Pharmaceuticals, Inc., a biotechnology company focused on the
development of antiviral therapeutics, today announced that its Scientific
Advisory Board (SAB) completed a comprehensive review of the current in vitro
and in vivo data for its lead HIV drug, KP-1461. The SAB concluded that recently
completed in vitro serial passage studies corroborated the original published
data, demonstrating that KP-1212, the active form of the oral prodrug KP-1461,
ablated HIV in equivalent laboratory experiments. Additional studies are
underway to assess ablation with greater sensitivity. 

The SAB also reviewed statistical analyses of in vivo data from clinical trials
of KP-1461. They concluded that KP-1461 demonstrated a statistically significant
decrease in HIV RNA at the highest dose level as compared to placebo in the
Phase 1b study. Decreases in HIV RNA were seen in some patients in Koronis`
Phase 2a study, though the results were not statistically significant. Each
clinical study met its primary endpoint of demonstrating that KP-1461 was
generally safe and well tolerated. 

"The current data confirms that the drug results in a substantial loss of HIV in
tissue culture, demonstrates antiviral activity in HIV-positive patients and
supports the continued development of KP-1461 and Viral Decay Acceleration,"
stated James Mullins, Ph.D., Professor of Microbiology and Medicine at
University of Washington and Koronis SAB Chair. 

According to Dr. Mullins, "Koronis has shown that in a repeat of previous work
KP-1461 reduces HIV titer to below detectable levels without noting the drug
resistance that is seen with currently approved HIV drugs. This demonstration of
the VDA mechanism, if confirmed by further clinical studies, will dramatically
alter the treatment paradigm for HIV patients." 

Koronis is in the process of completing formulation refinement and designing the
next clinical studies of KP-1461. 

About Koronis

Koronis Pharmaceuticals, Inc. is a privately held biotechnology company
developing anti-viral therapeutics based on a novel mechanism, Viral Decay
Acceleration (VDA). The Company`s lead product candidate is KP-1461 for the
treatment of human immunodeficiency virus (HIV). The Company also has products
in development for the treatment of hepatitis C and RSV. For more information on
Koronis, please visit www.koronispharma.com. 





Rathbun Communications, Inc.
Julie Rathbun, 206-769-9219
julie@rathbuncomm.com



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